Dosing & Uses
Dosage Forms & Strengths
taurolidine/heparin
catheter lock solution
- 13.5mg/1,000units/mL (3-mL, 5-mL single-dose vials)
Catheter-related Bloodstream Infections
Indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adults with kidney failure receiving long-term hemodialysis (HD) through a central venous catheter (CVC)
NOTE: Use is limited to a specific patient population
For instillation into CVCs only
Not intended for systemic administration
Do NOT use as a catheter lock flush product
Use 3-mL or 5-mL single-dose vial (depending on volume of catheter lumens) to instill taurolidine/heparin into each catheter lumen after completing each HD session
Before initiating next HD session, aspirate taurolidine/heparin from catheter and discard
Dosing Considerations
Limitation of use
- Safety and efficacy not established for use in populations other than adults with kidney failure receiving long-term HD through a CVC
Safety and efficacy not established
Adverse Effects
>10%
Hemodialysis catheter malfunction (17%)
Loss of catheter patency: Use of a thrombolytic agent (12%)
1-10%
Hemorrhage (7%)
Loss of catheter patency: Catheter removal (7%)
Nausea (7%)
Vomiting (6%)
Dizziness (6%)
Loss of catheter patency: Catheter removal without thrombolytic use (4%)
Musculoskeletal chest pain (3%)
Thrombocytopenia (2%)
<1%
Hypersensitivity (0.5%)
Heparin-induced thrombocytopenia (0.3%)
Metabolism and nutrition disorders: Hypocalcemia
Nervous system disorders: Dysgeusia
Postmarketing Reports
Nervous system disorders: Paresthesia
Warnings
Contraindications
Known heparin-induced thrombocytopenia (HIT)
Known hypersensitivity to taurolidine, heparin, citrate excipient, or pork products
Cautions
HIT reported; if HIT occurs, discontinue and institute appropriate supportive measures
Drug hypersensitivity reactions may occur; if a hypersensitivity reaction occurs, discontinue and institute appropriate supportive measures
Pregnancy & Lactation
Pregnancy
Not intended for systemic administration
Maternal use is not expected to result in fetal drug exposure
No animal reproduction study was conducted
Lactation
Not intended for systemic administration
Breastfeeding not expected to result in exposure to infant
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Taurolidine: Thiadiazinane antimicrobial agent with broad antimicrobial activity against gram-positive and gram-negative bacteria, as well as mycobacteria; also has antifungal effects
Heparin: Anticoagulant inhibits activated coagulation factors involved in clotting, especially factors Xa (low dose) and IIa (higher dose); prevents formation of a stable fibrin clot by inhibiting activation of fibrin stabilizing factor
Administration
Central Venous Catheter (CVC) Administration
Instill into CVCs only
Not for systemic administration
Do not use as a catheter lock flush product
Withdraw sufficient volume of catheter lock solution (CLS) from vial using a sterile needle and syringe to fill catheter lumens
Use 3-mL or 5-mL single-dose vial (depending on volume of catheter lumens) to instill into each catheter lumen after each hemodialysis (HD) session
Before next HD session, aspirate taurolidine/heparin from catheter and discard
Each vial designed for use with a single patient as a single instillation in CVC
Discard any unused portion remaining in vial
Storage
Store at controlled room temperature of 20-25ºC (68-77ºF), excursions permitted to 15-30ºC (59-86ºF)
Do not freeze
Must be stored in commercial carton before instilling into CVC
Images
Formulary
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